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The application fees for medical device registration in the United States vary depending on several factors, including the type of submission and the classification of the device. The U.S. Food and Drug Administration (FDA) charges fees for different types of submissions, such as premarket notification (510(k)), premarket approval (PMA), de novo classification requests, and other types of applications.

For fiscal year 2024, the FDA's fee schedule categorizes medical device applications into different tiers based on the type and complexity of the submission:

1. Premarket Notification (510(k)): This submission is required for moderate-risk devices (Class II). The standard fee for a 510(k) application is $12,858 for FY 2024.

2. Premarket Approval (PMA): High-risk devices (Class III) typically require a PMA application, which involves more extensive clinical data and review. The fee for a standard PMA application is $365,657 for FY 2024.

3. De Novo Classification Request: Devices that do not fit within existing classification schemes and are not substantially equivalent to any legally marketed device are eligible for the De Novo pathway. The fee for a De Novo request is $91,414 for FY 2024.

4. Other Types of Applications: Fees also apply to other types of submissions, such as requests for expedited review, panel-track supplements, and 180-day supplements, each with their respective fee schedules.

It's important to note that these fees are subject to annual adjustments by the FDA and can vary based on factors such as the size of the business submitting the application and whether the device qualifies for a reduced fee under the Small Business Determination.

These fees cover the FDA's costs associated with the review and evaluation of the application, including clinical trial oversight, facility inspections, and administrative expenses. Payment of these fees is typically required at the time of submission and is non-refundable, regardless of whether the application is approved.

Understanding the specific fee structure and requirements for each type of submission is crucial for manufacturers seeking FDA approval to market their medical devices in the United States. Compliance with FDA regulations and timely submission of fees ensure that devices meet rigorous standards for safety, efficacy, and quality, facilitating their entry into the U.S. healthcare market.

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